Arterial Blood Gas Analysis in Laparoscopic Cholecystectomy

NCT03133494 | Completed DMC

• 1 other identifier: 2014-15/EC/1219
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigator found out that as such the base line carbon dioxide (CO2) level is higher in smokers as compared to non-smokers even before creation of pneumoperitoneum, which is due to the compromised lung function following chronic smoking. This condition gets aggravated after creation of pneumoperitoneum which is very much evident from the serial arterial blood gas analysis. The level of CO2 remains elevated even after deflation of the pneumoperitoneum. Hence one has to be very much vigilant not only during intra-operative period but also in post-operative care unit. Hence serial ABG monitoring should be included as a part of the protocol especially in laparoscopic surgeries.

Conditions

Cholecystectomy, Laparoscopic

Outcome Measures

Primary Outcomes (1)

• Arterial blood gas parameter like potential of hydrogen (PH)

  Above parameter was measured by serial ABG analysis

  10 minutes before starting to 30 minutes after completion of surgery

Secondary Outcomes (3)

• Arterial blood gas parameter like partial pressure of carbon dioxide (PCO2)

  10 minutes before starting to 30 minutes after completion of surgery

• Arterial blood gas parameter like bicarbonate(HCO3)

  10 minutes before starting to 30 minutes after completion of surgery

• Arterial blood gas parameter like base excess (BE)

  10 minutes before starting to 30 minutes after completion of surgery

Study Arms (2)

Laparoscopic cholecystectomy in smokers

ACTIVE COMPARATOR

ABG analysis of patients with history of smoking posted for laparoscopic cholecystectomy was collected

Other: ABG analysis

Laparoscopic cholecystectomy nonsmokers

PLACEBO COMPARATOR

ABG analysis of patients without history of smoking posted for laparoscopic cholecystectomy was collected

Other: ABG analysis

Interventions

ABG analysis OTHER

ABG analysis was performed and compared between two groups

Laparoscopic cholecystectomy in smokers; Laparoscopic cholecystectomy nonsmokers

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American society of Anesthesiology (ASA) grade 1 and 2
• History of smoking (more than 20 pack year) for more than 10years

You may not qualify if:

• Patients refusal
• ASA grade 3 and 4
• Other lung pathologies
• Other cardiac pathologies
• uncontrolled diabetes mellitus
• systemic infection
• emergency operation
• history of malignancy
• history of alcohol or drug abuse

Sponsors & Collaborators

• Banaras Hindu University: lead

Study Officials

• PUSKAR RANJAN, MD, PhD

  Banaras Hindu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: abarik, Final year resident, Department of Anesthesiology, Institute of Medical Sciences

Model Details: Arterial blood gas sample was drawn from both the groups and analysed for any change in the desired parameters

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: April 28, 2017
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 17, 2017

Record last verified: 2017-05